Grant: Operating Grant: Clinical Trials Projects-Canadian sites of international trials

Patients who are critically ill in the Intensive Care Unit, especially those who need breathing machines, can develop complications including ulcers in the stomach which may bleed. To prevent this bleeding, most patients on a breathing machine receive a drug that reduces acid production in the stomach - commonly one called pantoprazole. However, patients today seem less likely to develop bleeding from the stomach compared to decades ago, possibly related to more advanced medical practices, such as earlier feeding. Moreover, in recent studies, some bleeding events do not seem concerning since patients do not need diagnostic tests, blood transfusions, or other treatments. Also, there are possible harms associated with acid suppression, including common problems such as infections in the lungs (pneumonia) and bowels (Clostridioides difficile). Finally, some studies have suggested an increased risk of death in the most seriously ill patients who receive acid suppression. The goal of this ongoing international study is to test whether, in critically ill patients needing a breathing machine, acid suppression with pantoprazole is effective in preventing bleeding from the stomach, and whether pantoprazole affects the risk of lung infections, bowel infections or death, or whether pantoprazole has no effect at all. Even though pantoprazole is not expensive per dose, an associated economic analysis will also help to find out whether there are benefits and the benefits are worth the costs. Patients are being recruited in 55 Intensive Care Units in Canada, Australia, Saudi Arabia, the United Kingdom, United States and Kuwait, with centers in Brazil and Pakistan starting soon. As of July 1, 2022 there have been 2,645 patients enrolled, representing 55% of the target number of 4,800 patients. With additional funding to complete this carefully designed study, it will be the largest trial conducted to date on this topic and will influence practice worldwide.